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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K091943
Device Name POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
Applicant
Cardiac Science Corporation
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact BEVERLY MAGRANE
Correspondent
Cardiac Science Corporation
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact BEVERLY MAGRANE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received06/30/2009
Decision Date 09/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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